Structure and Design of Aseptic Inspection Isolator
1. Air handling system
The isolator used for sterile testing needs to be equipped with a sterilization filter (HEPA is required). When static, it is required that the dust particles inside the isolator meet the Class 100 air quality requirements of the US Federal Standard 209E.
During dynamic operation, it is not required for the isolator to meet the 100 level air quality requirements, nor is it required for the air flow rate or ventilation rate inside the isolator to meet a certain standard. The isolator system is capable of preventing leakage, however, it is not the usual way to prevent the isolator from exchanging air with the external environment.
When directly connected to the external environment, the positive pressure inside the isolator ensures that the sterile environment inside the isolator is not contaminated. The air flow inside the isolator used for aseptic testing can be unidirectional or turbulent.
2. Transfer interface and transfer gate
The sterile inspection isolator has an attached "transmission channel" sterilizer, which can directly transfer sterile culture medium, sterile diluent, sterile equipment, etc. into the isolator system through the transmission channel sterilizer. It is generally designed as a fast transfer warehouse or door, which can connect two isolators to each other through the fast transfer warehouse or door, allowing sterile items to be transferred from one isolator to another. By quickly transferring the warehouse, two isolators or one isolator and one container can be connected in a normal environment. Connect the non sterile surfaces of the transfer chamber through sealing rings or flanges. Tighten with a gasket to ensure airtightness and prevent microorganisms from entering.
When two transfer chamber flanges are connected to form a sealed channel, there is a narrow gasket strip that may be contaminated by microorganisms in this area. Therefore, once the connection is complete, the exposed part of the gasket must be immediately treated with a sporicidal agent before using the transfer chamber to transfer items.
And when transferring items, attention should be paid to the use of sterile operating techniques to avoid contact between items or gloves and the surface of the gasket.
When assembling the gasket on the flange, preventive maintenance and lubrication should be carried out according to the recommendations of the transfer warehouse manufacturer. The transfer warehouse gasket should be regularly replaced and inspected according to the manufacturer's recommended requirements. Damaged gaskets cannot guarantee true sealing.